(259 days)
The MR Endoscope by Tronnier (Magnetic Resonance) allows visual observation of the operating site with simultaneous utilization of the working, supply and drain channels.
The Obturator is used for atraumatic insertion of the endoscope.
For examination, diagnosis and therapy in neurosurgery in conjunction with endoscopic accessories during intracranial procedures, such as: the fenestration of cysts, the removal of cysts, biopsies of lesions, coagulation of intraventricular lesions, etc.
NOTE: The MR Endoscope is specially designed for use in open nuclear magnetic resonance tomographs.
The submitted endoscope set is equivalent to standard endoscopes with a working channel, but for the use in magnetic resonance applications.
The provided document does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of typical AI/ML medical device performance evaluations.
Instead, this document is a 510(k) summary for an endoscope set, which is a physical medical device, not an AI/ML software. The crucial sections for answering your request are 5.0 Performance Data and 6.0 Clinical Tests.
Here's a breakdown based on the provided text, highlighting the absence of information relevant to your AI/ML questions:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to international standards IEC 601-1 and IEC 601-2-18 for medical electrical equipment. | The devices are conforming to the international standards IEC 601-1 and IEC 601-2-18. |
| Thermal heat rise verification to be within acceptable levels. | Thermal heat rise has been verified to be within acceptable levels. |
| Safety and effectiveness when used according to the instructions manual. | These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual. |
2. Sample size used for the test set and the data provenance
- No information provided. The "performance data" refers to engineering tests against standards, not a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There was no clinical test set for which ground truth would be established by experts.
4. Adjudication method for the test set
- Not applicable. No clinical test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI-assisted device. The document explicitly states "No clinical tests performed."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used
- Not applicable for the kind of ground truth usually associated with AI/ML. The "ground truth" here refers to whether the device physically met engineering standards.
8. The sample size for the training set
- Not applicable. There is no AI model or training set.
9. How the ground truth for the training set was established
- Not applicable. There is no AI model or training set.
Overall Conclusion:
The provided document describes a traditional medical device (an endoscope set) and its submission for 510(k) clearance based on substantial equivalence to existing devices and compliance with relevant engineering standards. It does not involve AI/ML technology, clinical performance studies with patient data, or the use of expert-derived ground truth as would be relevant for an AI/ML device.
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MAR 2 1 2003
15022198
12.0 510(k) Summary of Safety and Effectiveness
| Submitter: | ||
|---|---|---|
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | |
| Division name (if applicable): | N.A. | |
| Street address: | 353 Corporate Woods Parkway | |
| City: | Vernon Hills | |
| State/Province: | Illinois | |
| Country: | USA | |
| ZIP / Postal Code: | IL 60061 | |
| Contact name: | Mr. Robert L. Casarsa | |
| Contact title: | Quality Assurance Manager | |
| Date of Preparation: | July 1, 2002 | |
| FDA establishment registration number: | 14 184 79 | |
| Phone number (include area code): | ( 847 ) 913 1113 | |
| FAX number (include area code): | ( 847 ) 913 0924 | |
| Product Information: | ||
| Trade name: | Endoscope set for magnetic resonance (MR) | |
| Model number: | 8767.412, 8767.121, 8767.452 | |
| Common name: | Endoscopes, rigid | |
| Classification name: | Endoscopes, neurological | |
| Information on devices to which substantial equivalence is claimed: | ||
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
| 1 K970162 | 1 Neurological Endoscope Set | 1 Richard Wolf |
| 2 K973405 | 2 Endoscopic Spine System | 2 Richard Wolf |
1.0 Description
The submitted endoscope set is equivalent to standard endoscopes with a working channel, but for the use in magnetic resonance applications.
2.0 Intended Use
The MR Endoscope by Tronnier (Magnetic Resonance) allows visual observation of the operating site with simultaneous utilization of the working, supply and drain channels.
The Obturator is used for atraumatic insertion of the endoscope.
The MR Endoscope is specially designed for use in open nuclear magnetic resonance tomographs for examination, diagnosis and therapy in neurosurgery in conjunction with endoscopic accessories during intracranial procedures, such as: the fenestration of cysts, the removal of cysts, biopsies of lesions, coagulation of intraventricular lesions, etc.
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3.0 Technological Characteristics
The ferromagnetic device materials are replaced by nickel silver or titanium
4.0 Substantial Equivalence
The submitted devices pose the same type of questions about safety or effectiveness as the compared devices and the new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing devices sold by Richard Wolf.
5.0 Performance Data
The devices are conforming to the international standards IEC 601-1 and IEC 601-2-18. Thermal heat rise has been verified to be within acceptable levels.
6.0 Clinical Tests
No clinical tests performed.
7.0 Conclusions Drawn
These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual.
By: Robert J. Casares
Robert L. Casarsa Quality Assurance Manager
Date: July 1, 2002
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with its wings spread, formed by three curved lines that resemble human profiles. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 1 2003
Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills. Illinois 60061
Re: K022198
Trade/Device Name: Rigid Endoscopes Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological endoscope Regulatory Class: II Product Code: GWG Dated: December 20, 2003 Received: December 23, 2003
Dear Mr. Casarsa:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Robert L. Casarsa
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Mark n Millenn
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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5.0 INDICATIONS FOR USE
510(k) Number (if known): --
- Rigid Endoscopes Device Name:
- The MR Endoscope by Tronnier (Magnetic Resonance) allows visual Intended use: observation of the operating site with simultaneous utilization of the working, supply and drain channels.
The Obturator is used for atraumatic insertion of the endoscope.
Indications and field of use: For examination, diagnosis and therapy in neurosurgery in conjunction with endoscopic accessories during intracranial procedures, such as: the fenestration of cysts, the removal of cysts, biopsies of lesions, coagulation of intraventricular lesions, etc.
NOTE: The MR Endoscope is specially designed for use in open nuclear magnetic resonance tomographs.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
| 510(k) Number | K022198 |
|---|---|
| --------------- | --------- |
| Prescription UsePer 21 CFR 801.109 | OR | Over-The Counter | |
|---|---|---|---|
| ---------------------------------------- | ------------------------------------------ | ---- | ------------------ |
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).